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Full text of "USPTO Patents Application 09632741"

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Serial No. 09/632,741 



PATENT 



Claims 1-64 are pending this application. Previously, a provisional election was made by 
Applicants to prosecute the invention of Group I, species la and 2d, claims 1-5, 7-9, 1 1, 
13-26, 28, 30-38 and 40-44. Claims 6, 10, 12, 27, 29, 39 and 45-46 were withdrawn 
from further consideration as being drawn to a non-elected invention. By this 
Amendment, Applicants have amended claims 14, 18, 31, 33 and 41. The amendment to 
these claims have been made to correct the informalities appearing in the claims and to 
respond to the rejections under 35 U.S. C. § 1 12, 2 nd paragraph, as being indefinite for 
failing to particularly point out and distinctly claim the subject matter which Applicants 
regard as the invention. These amendments were not made to distinguish the invention 
over the cited prior art. 

Applicants note that the Examiner has objected to the drawings under 37 
C.F.R. § 1.83(a). In this regard, the Examiner has indicated that the Applicants should 
correct the drawings to show that the sheath is secured to the distal end of the catheter 
tube, as is required by claim 35. However, Applicants believe that such a structure is 
shown in FIGS. 1-6. Specific reference is made to the specification, namely page 13, 
lines 19-26, which states that the detachable sheath has a distal end that may be glued, 
bonded, heat shrunk or otherwise secured to the distal end of the catheter tube and/or the 
distal end of the elongated tubular member 22. The drawings show the sheath secured to 



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the catheter tube. Accordingly, Applicants have not submitted proposed drawing 
corrections with this reply but would be willing to further discuss the matter with the 
Examiner if requested. 

Claims 1-5,7-9, 11, 13, 16-31,33-41,43 and 44 were rejected under 35 
U.S.C. § 103(a) as being unpatentable over U.S. Patent No. 5,749,852 to Schwab, et al. 
(the "Schwab patent") in view of U.S. Patent No. 5,843,027 to Stone et al. (the "Stone 
patent"). Applicants strongly disagree with the Examiner's interpretation of the catheter 
assembly disclosed in the Schwab patent. The Examiner has relied on the embodiment of 
FIG. 12, showing perfusion openings (32) configured on a sheath, which the Examiner 
claims is capable of being ruptured during expansion of the expandable member. 
However, the Schwab patent fails to disclose or even slightly suggest that the spiral 
balloon (10) should be inflated or over-inflated to rupture the sheath along these 
openings (32). In fact, the sheath arrangement and openings (32) are not intended to 
rupture as such an occurrence would prevent the sheath from performing its main 
function. Specifically, the particular embodiment of the catheter shown and disclosed in 
FIG. 12 of the Schwab patent utilizes a sheath (18) with openings (32) arranged to 
provide a means for diverting blood flow to side vessels extending from the main vessel 
in which the spiral balloon (10) is positioned. This sheath (18) is provided to create 



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perfusion channels with the lobes of the balloon (10) to allow blood to perfuse past the 
expanded balloon (10). As is shown in FIG. 12, when the spiral balloon is placed in its 
expanded position, the sheath (18) must remain fully intact in order to provide the 
necessary blood flow through the openings (32) which feed the side vessels extending 
from the main vessel. The catheter shown in the Schwab patent must maintain the 
sheath (18) with openings (32) intact to adequately supply blood flow to the side vessels. 
The Schwab patent is completely devoid of any teaching which would suggest that the 
spiral balloon could be overinflated to cause the sheath to rupture since the rupturing of 
the sheath would destroy the blood perfusion channel and would certainly prevent the 
openings (32) from diverting blood flow to side branches. A rupture also could possibly 
cause portions of the sheath to block the channel formed between the sheath and spiral 
balloon. Therefore, the Schwab patent simply fails to disclose the feature of a sheath 
being configured to rupture during expansion of the expandable member. In fact, as 
expressed above, quite the opposite is taught by the Schwab patent since it would be 
detrimental if the sheath used in the FIG. 12 embodiment were to rupture. Accordingly, 
Applicants believe that the Schwab patent fails to disclose the basic concept of the 
present invention. 

Moreover, the Stone patent fails to teach or even remotely suggest the 



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elements of the present invention. The sheath described in the Stone patent is simply 
used to modify the expansion characteristics of the balloon onto which a stent can be 
mounted. Moreover, the Stone patent fails to teach or suggest that the sheath could be 
ruptured or that the stent could be mounted beneath the sheath. Rather, the stent in the 
Stone patent is shown mounted on the outside of the sheath which is placed over the 
balloon to modify the expansion characteristics of the balloon. Therefore, the particular 
combination of the Schwab patent with the Stone patent simply fails to achieve the 
structure recited in the claims at issue. Applicants respectfully request the Examiner to 
withdraw the obviousness rejections based on these cited references. 

Claims 14, 15, 32 and 42 were rejected under 35 U.S.C. § 103(a) as being 
unpatentable over the Schwab patent in view of U.S. Patent No. 6,302,874 to Makower 
et al. 5 (the "Makower patent"). As is discussed above, the Schwab patent fails to disclose 
the basic concept of the present invention. The Makower patent is cited for showing a 
catheter formed from a polyurethane. However, the Makower patent shows none of the 
particular combination of elements of the present invention. Therefore, the combination 
of the Stone patent with the Makower patent also fails to achieve the structure recited in 
the claims at issue. As such, Applicants respectfully request that the Examiner withdraw 
the obviousness rejections addressed to the present claims. 



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In view of the foregoing, it is respectively urged that all of the present 



claims of the application are patentable and in a condition for allowance. The 
undersigned attorney can be reached at 310-824-5555 to facilitate prosecution of this 
application, if necessary. 



Attached hereto is a marked up version of the changes made to the 



specification and claims by the current Amendment. The attached page is captioned 
"Version With Markings To Show Changes Made." 



THM:mem 

Enclosures: 

Requst for One-month Extension of Time 
Return Postcard 

Howard Hughes Center 
6060 Center Drive, 10 th Floor 
Los Angeles, California 90045 
Tel. No.: (310) 824-5555 
Fax No.: (3 10) 824-9696 
USPTO Customer No. 24201 



Respectfully submitted, 

FUL WIDER PATTON LEE & UTECHT, LLP 




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"VERSION WITH MARKINGS TO SHOW CHANGES MADE" 



14. (Amended) The catheter assembly of claim 1, wherein: 
the sheath is formed from [ESTANE] polvurethane with a shore hardness 
of 45D or lower. 

18. (Amended) An apparatus for delivering an endoprosthesis within a 
body lumen, comprising: 

an endoprosthesis; 

means for delivering the endoprosthesis within a body lumen, the means 
for delivering having a proximal end portion and a distal end portion; 

means for expanding the endoprosthesis, the means for expanding 
associated with the distal end portion of the means for delivering, wherein the 
endoprosthesis is disposed on the means for expanding; and 

means for retaining the endoprosthesis, the means for retaining being 
disposed on the means for delivering and over the endoprosthesis, wherein the means for 
retaining is configured to [detach from the means for delivering] rupture to allow the 
endoprosthesis to expand into a deployed position when inflation fluid is introduced into 



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the means for expanding. 

31. (Amended) The apparatus of claim 18, wherein: 

the means for retaining is formed from [ESTANE] polvurethane. 

33. (Amended) The apparatus of claim 18, wherein: 

the means for retaining is formed from a material selected from the group 
consisting of polyurethanes, polyetheretherketone, polyether amides, [polyurethane,] 
copolyesters, and expandable polytetrafluoroethylene. 

41. (Amended) The catheter assembly of claim 35, wherein: 
the sheath is formed from [ESTANE] polyurethane. 



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